The Food and Drug Law Course

Requisition # 1105475 The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-31. This announcement constitutes the only solicitation and a written solicitation will not be issued. The synopsis, NAICS code 541110, is to notify vendors that the government intends to issue a firm fixed price Purchase Order in accordance with FAR Part 13.106, for the following statement of work, under the simplified acquisition procedures. This solicitation is issued as a Request for Quotes/Proposals. STATEMENT OF WORK Project Title "Introductory Food and Drug Law Course" Background: The Food and Drug Administration (FDA), Center for Device and Radiological Health (CDRH), is committed to delivering effective and timely training to all of its employees. This course is recommended for all new hires and required of all CDRH reviewers as part of the Reviewer Certification Program. Objectives/Scope: The objective of this procurement is to develop and conduct a total of five (5) two-and-a-half-day (20 hours) Introduction to Food and Drug Law courses, to be held at the FDA White Oak campus in Silver Spring, MD, or other local off-campus site, for approximately 50 students; with an option to conduct two (2) additional courses. The scope of this introductory course ranges from this country's basic legal system down to showing how particular regulations and programs become inter-related in a CDRH employee's job now. By the end of the course, CDRH employees should have a clearer understanding of how their jobs are relevant to consumer protection. Tasks: 1. The Contractor shall participate in conference calls with CDRH Staff College strategists to update the agenda for the Introductory Food and Drug Law course. The conference calls shall be conducted approximately one (1) month prior to each course and consist of a discussion of logistics for the training sessions and any updates needed to the agenda and/or presentations. 2. The Contractor shall be on-site to set up and make preparations for the training course prior to the start of each training course, for approximately one (1) hour to ensure that all AV equipment, presentation materials, or additional requirements have been met. 3. The Contractor shall develop and provide course materials for the training on CDs or USB drives according to the attached agenda based on a 2- day, 20-hour total program. 4. The Contractor shall be actively involved with various stages of preparation for the Introductory Food and Drug Law training course, including the conference calls and communication with Staff College strategists. Conference call dates will be determined by mutual agreement of the Contractor and the Contracting Officer Representative (COR). 5. The Contractor shall facilitate all presentations during each training course. Travel costs expended by the Contractor will be reimbursed in accordance with Federal Travel Regulations. Deliverables: 1. The Contractor shall develop and send course material and related information for the lectures to the Staff College contact by no later than two (2) weeks prior to the start of each course date. 2. The Contractor shall conduct a total of five (5), two-and-a-half-day Introduction to Food and Drug Law courses, to be held at the FDA White Oak campus in Silver Spring, MD, for approximately 50 students; with an option to conduct two (2) additional courses. Period of Performance: The Government anticipates a twelve (12)-month performance period for this procurement. Course Location: White Oak, Silver Spring, Maryland 20993, or other local off-campus site. Basis for Award: Award will be made to the party whose quotation offers the best overall value to the Government, technical and price factors considered. The Government will evaluate quotations based on the following evaluation criteria: 1) Technical Approach and Understanding, 2) Relevant Experience, and 3) Price. The Technical Approach and Understanding and Relevant Experience factors are of equal importance and, combined, these two factors are more important than the price factor. If two or more quotations are determined to be approximately equal technically, price may become the determining factor in selecting the awardee. In any event, the Government reserves the right to make an award to the best advantage of the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. Evaluation Factors Factor 1 - Technical Approach and Understanding: 1.) Quotations will be evaluated based upon the soundness, completeness and feasibility of the Quoter's technical approach for successfully performing the requirements and demonstrating an understanding of the scope, purpose, intent of the Statement of Work tasking. The Quotation should include a statement of the overall project objectives and the specific accomplishments that will be achieved. The Quotation should also include a description of the rationale for the Quoter's plan and the relationship to any comparable past work or work in progress that the Quoter is performing. 2.) Quotations will be evaluated based upon the Quoter's demonstrated recognition and ability to overcome potential difficulties in the performance of the project. The Quotation should include a description of potential difficulties that may be encountered during the project and the proposed solutions. Factor 2 - Relevant Experience: Quotations will be evaluated based upon the Quoter's: a. Demonstrated experience in Food and Drug Law and in providing Food and Drug Law training, with an emphasis on medical devices. b. Demonstrated experience in teaching groups of professionals. Quotations should: 1) include a description of the Quoter's relevant experience demonstrating the ability to fulfill this requirement; 2) identify other organizations for which you have provided the same or similar services, and 3) describe the degree of your involvement, the size and complexity of the organization and any other information describing your experience. Factor 3 - Price: Quotations will be evaluated for price reasonableness to the extent necessary as described in FAR 13.106-3(a). CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the purchase order. You may register by going to www.ccr.gov. You will need to your Tax ID, Duns Number, Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later August 7, 2012 10:00 AM EST. QUOTATIONS DUE: All quotations are to be submitted via email to Vida.Niles@fda.hhs.gov, no later than 10:00 AM, EST on August 24, 2012. Responses to this notice shall be sent via email to Vida.Niles@fda.hhs.gov, NO Telephone calls will not be accepted.